EMCM - Supporting opportunities

EMCM is the centre of excellence in developing and manufacturing sterile medicinal products in GMP and ISO accredited facilities that cater to the markets of innovative Biomaterials, Pharmaceuticals and Tissue Engineering specialties conforming to the standards of the USFDA, EMEA and ISO.

Supporting opportunities in healthcare

As a customer driven organisation that believes in contributing to the quality of life by delivering high quality products and services, EMCM incorporates a "no-compromise on quality" policy, your innovations are delivered in the safest of environments.

EMCM prides itself in being able to support innovations and breakthroughs in the healthcare sector that will positively impact the lives of millions worldwide. If you have an opportunity, you can rest assured EMCM will support you whilst you deliver them, through:

• B2B model for the development and manufacturing
• Compliant and reliable quality systems
• End-to-end service solutions
• Upscaling, process validation, production, packaging, warehousing and distribution
• Fully licenced GMP operations / European and FDA approved Tissue licence to store, process and distribute human tissue
• Support in sales and product registration
• Flexibility to ensure your innovation is on the market

Contract manufacturing of sterile medicinal products

Whilst we can assist in process optimisation & validations and upscaling, our core expertise lies in customised routine batch production with competent formulations, processing and filling coupled with a variety of terminal sterilisation techniques as per the requirements or a complete aseptic manufacturing closed system.

Organic solvents, aqueous solutions and suspensions can be produced from small to large scale with a fully automatic closed dosing system to provide a customer specific bulk product. Sterile filtration results in a sterile product for in-line automatic filling.

The production of highly viscous products, like temperature dependent suspensions and gels, is one of the existing expertise and technologies are in place to manufacture these groups of products.

The formulation of all liquids, suspensions & gels (LSG) and can be executed under class A/B aseptic condition before filling in the required primary packaging.

For more detailed information please read our LSG brochure.

Ampoule, syringe, vial and pouch filling

EMCM is equipped with a range of (semi-) automatic filling units for the filling of organic solvents, aqueous solutions, gels and suspensions as well as powders. All filling processes can be performed under aseptic conditions and will be validated by media simulations according GMP and ISO requirements:

• Ampoule filling: two fully automatic filling units for the aseptic filling of organic and volatile solvents and aqueous solutions into ampoules up to 30 ml are in operation. This aseptic process is validated by media simulation and executed by a qualified process team. This filling process can be further extended by inline labelling, a visual inspection machine and the positioning of an ampoule breaker
• Syringe filling: EMCM has a semi-automatic filling process for the filling of highly viscous suspensions and gels, in operation in the range of 1 ml - 5 ml syringes. This technology has scope to be expanded for the filling of dual syringes as well as a fully automatic pre-filled syringe (PFS) line
• Vial filling: a fully automatic filling unit for the (aseptic) filling of liquids, suspensions and gels in vials is in operation. The line is equipped with stopper/cap closure devices for 13 mm and 20 mm
• Pouch filling: on special customer request we design filling equipment for the filling of custom-made primary packaging. A dedicated custom-made filling line is available for the filling of liquids in aluminium pouches. This filling unit can be made suitable for filling of any dedicated filling unit

EMCM has also the possibility to fill powder into vials, pouches and small containers. An example is bone cement powder.

Orthopaedic biomaterials

EMCM currently possesses various types of bone cement, cement restrictors as well as an adhesion barrier product for spinal surgeries in its biomaterials portfolio.

Tissue Engineering, bone & tissue processing, allografts and xenografts

EMCM's Tissues business segment is active in the processing of tissue components such as bones, soft tissues, cells and skin of human (eTiss) and of animal origin (eColl), which can further be impregnated with antibiotics (eNova). Our capabilities are in providing safe, clean and effective bone, collagen and innovative products using proprietary supercritical carbon dioxide technology (eCOO | Technology).

For more detailed information, please download our Tissues brochure.

Centre of excellence in manufacturing sterile medicinal products

EMCM has grown from a start-up to a mid-sized company that employs over 60 FTE and operates in over 1500 m² of GMP accredited classified areas (clean rooms), conforming to ISO & GMP standards for compliant manufacturing of medical products.

Using such qualified facilities EMCM produces a broad range of medical products offering complete custom made service and product packages: from product development, through regulatory affairs, purchasing, manufacturing, final packaging, warehousing and distribution in the capacity of a contract manufacturer.

EMCM is always open to explore innovations and work flexibly with its customers. Please feel free to contact us regarding any questions.